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510(k) K182874

Fenom Pro Nitric Oxide Test by Spirosure, Inc. — Product Code MXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2019
Date Received
October 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Breath Nitric Oxide
Device Class
Class II
Regulation Number
862.3080
Review Panel
CH
Submission Type

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